Description:

ODM derived from http://clinicaltrials.gov/show/NCT00331890

Link:

http://clinicaltrials.gov/show/NCT00331890

Keywords:
Versions (2) ▾
  1. 12/11/13
  2. 4/14/14
Uploaded on:

April 14, 2014

DOI:
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License:
Creative Commons BY 4.0
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Eligibility NCT00331890 Acute Stroke. Cerebral Infarction.

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Patient, >18 years old
Patients must be treated within 24 hours of their initial stroke symptoms onset.
Patients with a measurable focal neurological deficit lasting for a minimum of 60 minutes.
Patients must have a CT scan and/or conventional MRI compatible with the clinical diagnosis of acute ischemic stroke prior to being randomized.
Patients must have an acute ischemic stroke referable to the middle cerebral artery territory
At inclusion, NIHSS score > 7, with at least 2 of these points from sections 5 & 6 (motor)
Immediately (i.e. minutes) pre-stroke, MRS < 2
Women of childbearing potential must have a negative pregnancy test prior to enrolment
Signed informed consent
Exclusion Criteria
Patients in coma: patients having a score of >=2 in the items regarding the level of consciousness in the NIHSS (1a)
CT or conventional MRI evidence of brain tumor, cerebral edema with a clinically significant mass midline shift with compression of the ventricles, brainstem or cerebellar infarction, subarachnoid and/or intracerebral and/or intraventricular hemorrhage
History of ventricular dysrhythmias, acute myocardial infarction within 72 hours prior to enrolment, unstable angina, decompensated congestive heart failure or any other acute, severe, uncontrollable or sustained cardiovascular condition that, in the Investigator's opinion, may interfere with effective participation in the study
Previous disorders that may confound the interpretation of the neurological scales
Drug addiction-related disorders
Pre existing dementia, when dementia implies a disability, measured as an score of >=2 in the previous MRS
Pre existing medical condition that, in the Investigator's opinion, may interfere with the patient's suitability and participation in the study
Patients participating in another clinical trial or receiving a non-approved drug (clinical investigational drug) <30 days prior to screening
Patients under current treatment with citicoline